凯悦欣软膏治疗肺胃蕴热型寻常痤疮有效性及安全性的临床研究

发布时间：2018-04-07 16:19

本文选题：寻常痤疮　切入点：肺胃蕴热型　出处：《成都中医药大学》2012年硕士论文

【摘要】：目的：通过本次研究进一步评价凯悦欣软膏治疗肺胃蕴热型寻常痤疮在改善皮损及相关症状等方面的有效性及安全性。方法：1、总体设计：阳性药平行对照(迪康粉刺霜)、随机、双盲、多中心临床试验的方法。2、治疗：温水洁面后,将所领药品(双盲、随机)均匀外用于患处,1-1.5g/次,3次/日,2周为1个疗程,连用4周。3、观察：受试者在初诊及治疗后2周、4周分别填写观察表格,记录皮疹类型、数量、形态、痒痛等中医证候的改善情况,询问用药依从性,记录不良反应。4、疗效评价：参照2002年版《中药新药临床指导原则(试行)》中“中药新药治疗寻常痤疮的临床研究指导原则”制定的疗效判定标准进行疗效观察,分别对治疗前、中、后受试者的中医证候、不良反应等情况进行如实记录并按照评分标准进行积分,每2周一次,揭盲后根据记录对治疗组及对照组进行疗效评价及安全性评价。结果：1、两组之间受试者性别、年龄、病程、治疗前中医证候主症及次症积分比较,差异均无统计学意义(P＞0.05),基线均衡,具有可比性。 2、综合疗效评价：两组组内在不同疗程(2周、4周)治疗前后的比较均有明显改善(P=0.00)；两组之间综合疗效在不同疗程的比较,差异均无统计学意义(P＞0.05),FAS(全分析数据集)与PPS(符合方案数据集)疗效结果一致。 3、中医证候疗效评价：两组组内在不同疗程(2周、4周)治疗前后的比较均有明显改善,(P=0.00)；两组之间中医证候改善情况在不同疗程的比较,差异均无统计学意义(P0.05),FAS与PPS疗效结果一致。 4、单项皮损症状(皮疹类型、数量、形态、痒痛等)疗效评价：两组组内在不同疗程(2周、4周)的比较均有明显改善；两组之间各皮损症状改善情况在不同疗程的比较,差异均无统计学意义(P0.05),FAS与PPS疗效结果一致。结论：1、凯悦欣软膏与迪康粉刺霜治疗肺胃蕴热型寻常痤疮在改善皮损及相关症状等方面的有效性及安全性相当,无显著性差异。 2、凯悦欣软膏治疗肺胃蕴热型寻常痤疮在改善皮损及相关症状等方面疗效确切,临床安全有效。
[Abstract]:Objective: to evaluate the efficacy and safety of Kaiyuexin ointment in the treatment of febrile acne vulgaris.Method 1, overall design: parallel control of positive drugs (Dickon acne cream, randomized, double-blind, multicenter clinical trial method .2.Therapeutic: warm water after facial cleaning, the drug was obtained (double-blind, double-blind, double-blind).The subjects were given a course of treatment for 2 weeks, followed by 4 weeks. Observation: the subjects filled out the observation form 2 weeks after the first visit and 2 weeks after treatment, and recorded the type, quantity and shape of the rash.The improvement of TCM syndromes, such as itching pain, asking about drug compliance,Record adverse reactions .4. curative effect evaluation: according to the guidelines for Clinical Research of New Chinese Medicine for the treatment of Acne Vulgaris, 2002 edition of the "Clinical guidelines for the treatment of Acne vulgaris", we observed the curative effect before treatment, respectively.The TCM syndromes and adverse reactions of the subjects were recorded truthfully and scored according to the scoring standard. Once every 2 weeks, the treatment group and the control group were evaluated for efficacy and safety according to the records.Results there was no significant difference between the two groups in sex, age, course of disease, the scores of main syndrome and secondary symptom of TCM before treatment (P > 0.05), and the baseline was balanced and comparable.2, comprehensive curative effect evaluation: the comparison between the two groups before and after different courses of treatment (2 weeks and 4 weeks) was significantly improved, and the comprehensive curative effect was compared between the two groups in different courses of treatment.There was no significant difference (P > 0.05) between FASs and PPSs.3. Evaluation of TCM syndromes: there were significant improvements in the two groups before and after treatment, and the improvement of TCM syndromes between the two groups was compared in different courses of treatment, and there was no significant difference between the two groups in the improvement of TCM syndromes in different courses of treatment, and the improvement of TCM syndromes was compared between the two groups in different courses of treatment.There was no significant difference between P0.05 and PPS.4, the curative effect evaluation of single lesion symptom (rash type, quantity, shape, itching pain, etc.): there was significant improvement in the two groups in different course of treatment, and the improvement of each lesion symptom in different course of treatment was compared between the two groups.There was no significant difference between P0.05 and PPS.ConclusionThe efficacy and safety of Kaiyuexin ointment and Dekang acne cream in improving skin lesions and related symptoms were comparable, but there was no significant difference between them in the treatment of feverish acne vulgaris with heat accumulation in lung and stomach.2. Kaiyuexin ointment is safe and effective in the treatment of acne vulgaris with heat accumulation in lung and stomach.
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：R758.733

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